Suture method

ABSTRACT

A method for joining and holding closed a wound in bodily tissue, fastening junctions of wounds, tying off wounds, joining a foreign element to tissue, and altering the position of tissue using a barbed suture including sharp pointed ends. Each end of the suture includes barbs on that permit movement in an opposing direction to the barbs on the other end of the suture. This two-way barbed suture is used by the method of the present invention in applications including abdominal surgeries such as a Nissen fundoplication, laparoscopic uses such as stabilizing a bowel structure and performing a closure of a cystostomy, liver to bowel anastomosis, closure of an orifice of a Zenker&#39;s Diverticulum, endoscopic uses such as closure of ulcerative lesions or and post-procedural tissue defects, bladder wound closure, valve replacement surgery, device attachment, cosmetic surgery, and blood vessel wound closure.

RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 10/065,256, filed Sep. 30, 2002, now U.S. Pat. No. 7,056,331,which is a continuation-in-part of U.S. patent application Ser. No.09/896,455, filed Jun. 29, 2001, now U.S. Pat. No. 6,599,310, thecontents of both of which are hereby incorporated by reference.

BACKGROUND

This invention relates generally to a method for joining bodily tissuein surgical applications and wound repair, and more particularly to asurgical suturing method for joining bodily tissue using a suture havinga plurality of barbs which permit the suture to be pulled through thetissue in one direction but resisting movement of the suture relative tothe tissue in the opposite direction.

Surgical or accidental wounds are typically closed with a length offilament introduced into the tissue by a sharp metal needle attached toone end of the filament. This device is known as a “suture”. Sutures areused to make “stitches” to close the wound for holding tissues togetherfor healing and regrowth. Sutures are used in surgical procedures forwound closure, to close the skin in plastic surgery, to secure damagedor severed tendons, muscles or other internal tissues, and inmicrosurgery on nerves and blood vessels. Generally, the suture needleis caused to penetrate and pass through the tissue pulling the suturethrough the tissue. The opposing faces of the tissue are then movedtogether, the needle is removed, and the ends of the suture are tied ina knot. The suture forms a loop as the knot is tied. The knottingprocedure allows the tension on the filament to be adjusted toaccommodate the particular tissue being sutured and control ofapproximation, occlusion, attachment or other conditions of the tissue.The ability to control tension is extremely important regardless of thetype of surgical procedure being performed.

Suturing is a time-consuming part of most surgical procedures,particularly in microsurgery and endoscopic surgery where there isinsufficient space to properly manipulate the suture. Loop sutures canleave scars where they penetrate skin. For adequate closure of somewounds, the suture material must be of a high tensile strength and thusa large diameter thereby increasing scarring. The loop suture alsoconstricts blood flow to the tissue it surrounds, promoting necrosis ofthe wound margins which compromises healing and increases infectionrisks. Further, the tissue is distorted as it is secured by the sutureloop due to excess tension on the knots. Localized tensions from theknots are the culprit for scar formation. The bulk of the knots are alsoan impediment to wound healing in internal applications.

Alternatives to conventional sutures for wound closure are known,including fasteners such as staples, clips, tacks, clamps and the like.The fasteners are usually positioned transversely across a wound forjoining or approximating each side of adjacent tissue layers laterally.Fasteners have relatively high strength and save time, but are not asaccurate as sutures and are bulky and may be painful to remove.Fasteners are also generally unsuitable for deeper layers of tissue.Moreover, fasteners do not provide the advantage of adjustable tensionobtained by the knotting of a length of suture material.

Surface adhesive tapes and glues are often used on skin to hold smallwounds closed to permit healing. However, these products have relativelylow tensile strength and are not useful in many situations.

Other techniques proposed include electrical coagulation and lasers.However, no acceptable alternative has been found which offers theadvantages of suturing and tying in most surgical procedures.

One possible alternative is a barbed suture. A barbed suture includes anelongated body having one or more spaced barbs projecting from thesurface of the body along the length of the body. The barbs areconfigured to allow passage of the suture in one direction throughtissue but resist movement of the suture relative to the tissue in theopposite direction. In wound closure, a barbed suture is passed throughtissue at each of the opposed sides of a wound. The wound is closed bypushing the sides of the wound together with the barbs maintaining thesutures in place and resisting movement of the tissue away from thisposition. The advantage of using barbed sutures is the ability to puttension in the tissue with less slippage of the suture in the wound. Thebarbed suture spreads out the holding forces evenly therebysignificantly reducing tissue distortion. Since knots do not have to betied, there is a time savings and the elimination of suture knotsimproves cosmetic effects and promotes wound healing. Barbed suturesalso allow better apposition of tissue since the incised or insultedtissues are brought together and secured with almost no movementimmediately. Unlike the conventional suturing method wherein tension isapplied by pulling on the end of the suture after placement, barbedsutures permit tissue to be approximated and held snug during suturing.This is especially advantageous in closing long incisions. The result isbetter healing when the tissue levels are harmoniously matched as thecosmetic effect is more pronounced at skin level. Moreover, if there isan accidental breakage of the barbed suture, the wound is minimallydisturbed. With conventional sutures, dehiscence would occur.

Despite the advantages offered by barbed sutures, the tensile strengthof a barbed suture is less than a loop suture of equivalent size. Thisis due to the reduced tensile strength resulting from imparting the barbstructure onto the body of the suture, which reduces its effectivediameter. This limitation is not significant since larger barbed sutureswith greater tensile strength can be utilized. However, the conventionalmethods for introducing barbed sutures into tissue still do not exhibitthe same biomechanical performance of looped sutures.

For the foregoing reasons there is a need for a suturing method forjoining tissue in surgical applications and wound repair which isefficient and expedites the surgical procedure. Ideally, the new methodallows a surgeon to suture in an efficient manner to quickly approximatetissue with appropriate tension. The new method should preserve bloodflow, improve wound healing strength, prevent distortion of the tissueand minimize scarring. The method should also incorporate theself-retaining benefits of the barbed suture with the holding power ofconventional suturing methods. A particularly useful method would beutilized in surgical applications where space is limited such asmicrosurgery, endoscopic surgery, or arthroscopic surgery.

SUMMARY

The present invention provides a way to close wounds, fasten junctionsof tissue, tie off wounds, join a foreign element to tissue, mount adevice to tissue, alter the position of tissue where there is only asingle portion of tissue without a wound or junction, and perform otherprocedures. The methods of the present invention are performed with atwo-way barbed suture. Specifically, the two-way barbed suture includesan elongated body, first and second sharp pointed distal ends forpenetrating the tissue, and a plurality of barbs extending from theperiphery of the body. The barbs on a first portion of the body betweenthe first end of the suture and a first axial location on the bodypermit movement of the suture through the tissue in a direction ofmovement of the first end, and prevent movement of the suture relativeto the tissue in a direction opposite the direction of movement of thefirst end. The barbs on a second portion of the body between the secondend of the suture and a second axial location on the body, which is lessthan the distance from the second end to the first axial location,permit movement of the suture through the tissue in a direction ofmovement of the second end, and prevent movement of the suture relativeto the tissue in a direction opposite the direction of movement of thesecond end.

In some embodiments of the present invention an insertion device is usedto insert the barbed suture. Such an insertion device is tubular and hasleading and trailing ends with openings therein. The suture is initiallydisposed in the insertion device. The first end of the suture isproximate to the leading end of the insertion device. Where no insertiondevice is used, the sharp pointed ends of the suture are used to insertthe suture in tissue; while these ends may be embodied, or be referredto, as needles herein, it should be understood that the suture mayterminate in any type of sharp pointed end.

Some embodiments provide a method for joining and holding portions of astomach to each other in the performance of a Nissen fundoplicationprocedure. The Nissen fundoplication procedure requires grasping thefundus of the stomach at a proximal location and pulling the fundusaround the esophagus, wrapping the fundus around the esophagus one timeand attaching the proximal stomach to an apposing portion of thestomach. One method that uses the sharp pointed ends of the barbedsuture to penetrate tissue comprises the steps of inserting the firstpointed end of the suture into tissue of the proximal stomach andpushing the first end of the suture through the stomach tissue until thefirst end of the suture extends out of the tissue at an exit point onthe exterior of the stomach. The first end of the suture is pulled todraw the first portion of the suture through the tissue until the secondaxial location is proximate to the point of insertion of the first endof the suture. A length of the first portion of the suture is left inthe tissue between the point of insertion and exit point of the firstend. The proximal stomach is gripped and the fundus is wrapped aroundthe esophagus until the proximal stomach contacts an apposing portion ofstomach. The second pointed end of the suture is inserted into tissue ofthe apposing stomach, and the second end of the suture is pushed throughthe stomach tissue until the second end of the suture extends out of thetissue at an exit point on the exterior of the stomach. The second endof the suture is pulled to draw the second portion through the tissueuntil the second axial location is proximate to the point of insertionof the second end of the suture and a length of the second portion ofthe suture is left in the tissue between the point of insertion and exitpoint of the second end.

In another embodiment of a Nissen fundoplication method, an insertiondevice is used. Again, the fundus is wrapped around the esophagus toform a junction with the apposing portions of stomach. Then the firstpointed end of the suture and leading end of the insertion device areinserted into stomach tissue at a point laterally spaced from thejunction and on a first side of the junction. The first end of thesuture and leading end of the insertion device are pushed through thefirst side of stomach tissue and penetrate the stomach tissue on asecond side of the junction until the portion of the suture between thefirst and second axial locations is proximate to the junction. Theinsertion device is removed by gripping and pulling the trailing end,leaving the suture in place.

Another embodiment for performing a Nissen fundoplication is providedusing both sharp pointed ends of the suture, comprising the step ofinserting the first pointed end of the suture into the tissue at a firstside of the junction formed by the wrapping of the fundus around theesophagus. The first end of the suture is pushed through the tissueuntil the first end of the suture extends out of the tissue at an exitpoint in the face of the junction below the surface of the tissue at thefirst side of the junction. The first end is pulled out of the tissue,drawing the first portion of the suture through the tissue until thesecond axial location is at the point of insertion of the first end ofthe suture. A length of the first portion of the suture is left in thetissue between the point of insertion in the first side of the junctionand the exit point in the face of the junction at the first side of thejunction. The first end of the suture is then inserted into the face ofthe tissue below the surface of the tissue at a second side of thejunction, and is pushed until the first end exits on the second side ofthe junction longitudinally spaced in a first direction from theinsertion point in the first side of the junction. The first end of thesuture is pulled out of the tissue and the first portion is drawn tobring the two sides of the junction together to a closed position alongthe first portion of the suture in the tissue. A length of the firstportion of the suture is left in the tissue between the point ofinsertion in the first side of the junction and the exit point in thesecond side of the junction. The process is repeated similarly for thesecond end and second portion of the suture.

Another method for joining and holding portions of a stomach to eachother in the performance of a Nissen fundoplication is provided, usingthe sharp pointed ends of the suture, which may be needles. The methodcomprises the steps of inserting the first pointed end of the sutureinto the stomach tissue below the surface of the stomach tissue at afirst face of the junction at an initial point. The first end of thesuture is pushed through the stomach tissue along a curvilinear pathuntil the first end of the suture extends from the stomach tissue at anexit point in the first face of the junction. This exit point islongitudinally spaced in a first direction from the insertion point inthe first face of the junction. The first pointed end of the suture isgripped and pulled until it is out of the stomach tissue, drawing thefirst portion of the suture through the stomach tissue until the secondaxial location is at the point of insertion of the first end of thesuture in the first face of the junction, leaving a length of the firstportion of the suture in the stomach tissue of the junction. The firstpointed end is inserted at a point below the surface of the stomachtissue in a second face of the junction, and pushed through the stomachtissue along a curvilinear path until the first end of the sutureextends from the stomach tissue at an exit point in the second face ofthe junction below the surface of the stomach tissue. Again, the exitpoint is longitudinally spaced in the first direction from the insertionpoint in the second face of the junction. Then the first end of thesuture is inserted at a point in the first face of the junction belowthe surface of the stomach tissue, and the above steps may be repeatedfor advancing along the junction in the first direction as necessary toone end of the junction. These steps are similarly repeated for thesecond end and second portion of the suture in a second direction. Theinitial point may be longitudinally spaced from the ends of the junctionor adjacent to an end, and the first and second directions may be theopposite or same directions.

One embodiment provides a method for laparoscopically inserting a barbedsuture with a laparoscopic insertion device, similar to the insertiondevice described above but included in a laparoscopic tool. The firstpointed end of the suture and the leading end of the laparoscopicinsertion device are inserted through an entry point in the skin, andthen through the fat, fascia, muscle, and peritoneum into the abdominalcavity. The first end of the suture and leading end of the insertiondevice are pushed into the tissue in the abdominal cavity, and theinsertion device is pulled at the trailing end to remove the insertiondevice. Additional embodiments include stabilizing a bowel structure,where the bowel structure is positioned and then stabilized by leavingthe inserted suture in place in the bowel tissue and the abdominal wall,and for a closure for a cytostomy, in which the first and second endsand portions of the suture are inserted in urinary bladder muscularis.

Another embodiment involves a method for performing an anastomosis ofthe liver bile duct to a bowel structure, the bile duct having one endconnected to the liver and a free end after having been severed, and thebowel structure having an opening in its wall made to receive theannular free end of the bile duct. One embodiment is performed with aninsertion device as described above, with steps comprising placing thefree end of the bile duct in contact with the opening in the bowelstructure, and forming a junction at the annular contact area betweenthe bile duct tissue and the bowel structure tissue. The first pointedend of the suture and the leading end of the insertion device areinserted into the tissue on one side of the junction. The first end ofthe suture and leading end of the insertion device are pushed throughthe tissue on one side of the junction, through the junction, andpenetrate the tissue on the other side of the junction. The insertiondevice is gripped and pulled at the trailing end to remove the insertiondevice, leaving the suture in place in both the bile duct tissue and thebowel structure tissue. The previous steps are repeated as necessary toprovide an anastomotic seal at the junction.

In another embodiment, a liver bile duct-to-bowel structure anastomosisis performed with needles. Here, the first pointed end of the suture isinserted into a first tissue at a point spaced from the junction of theduct and bowel structure. The first end of the suture is pushed throughthe first tissue until the first end of the suture extends out of thefirst tissue at an exit point and penetrates a second tissue at a faceof the junction. The first end of the suture is pushed until the firstend of the suture extends out of the second tissue at an exit pointspaced from the junction and spaced in a first direction along thecircumference of the junction from the point of insertion of the firstend of the suture in the first tissue. The first end of the suture isgripped and pulled out of a second tissue to draw the first portion ofthe suture through the first tissue and the second tissue while bringingthe first tissue and the second tissue together to a closed positionalong the first portion of the suture. This pulling continues until thesecond axial location is at the point of insertion of the first end ofthe suture at the one side of the first tissue, leaving a length of thefirst portion of the suture in the first tissue and the second tissuebetween the point of insertion and the exit point. Then the first end ofthe suture is inserted into the second tissue at the exit point of thefirst end. The first end of the suture is pushed through the secondtissue until the first end of the suture extends out of the secondtissue at an exit point in the face of the junction and penetrates thefirst tissue. This pushing continues until the first end of the sutureextends out of the first tissue at an exit point spaced from thejunction and spaced along the circumference of the junction in the firstdirection from the immediately preceding point of insertion of the firstend of the suture in the first tissue. Then first end of the suture ispulled out of the tissue to draw the first portion of the suture throughthe second tissue while bringing the first tissue and the second tissuetogether to a closed position along the first portion of the suture, andleaving a length of the first portion of the suture in the peripherybetween the point of insertion and the exit point. The above steps forthe first end and first portion may be repeated to achieve ananastomotic seal. In addition, the steps described above are repeatedsimilarly for the second end and second portion of the suture in asecond direction.

In another embodiment, a method for tying off an appendiceal stumpresulting from the performance of an appendectomy is provided, usingneedles. The appendix extends from the cecum of the large intestine andhas a base with a circumference at the juncture of the appendix and thececum. The first pointed end of the suture is inserted into tissue ofthe cecum proximate to the appendix base. The first end of the suture ispushed around the circumference of the base in one direction for atleast one half of the circumference of the base until extending throughan exit point in the tissue. The second pointed end of the suture isthen inserted into tissue of the cecum proximate to the entry point ofthe first end, and the second end of the suture is pushed along thecircumference of the base in the other direction for at least one halfof the circumference of the base until extending through an exit pointin the tissue. The appendix is excised, leaving the appendiceal stump.Then the ends of the suture are gripped and pulled, causing the sutureto tighten around the appendiceal stump, and may invert the stump intothe cecum.

Another embodiment provides a method for joining and holding closed themuscle layers that define the orifice of a Zenker's Diverticulum usingan endoscopic insertion device, similar to the insertion devicedescribed above but included in an endoscopic tool. The Zenker'sDiverticulum includes a sac extending from a proximal location of theesophagus near the pharynx, the sac having walls including a musclelayer common to the proximal esophagus. The Zenker's Diverticulum mayfirst be manually inverted into the esophagus, or left outside theesophagus. The first pointed end of the suture and the leading end ofthe endoscopic insertion device are inserted through an entry point inthe esophageal muscle between the pharynx and the orifice, and spacedfrom the orifice. The first end of the suture and leading end of theinsertion device are pushed through the muscle until the first end ofthe suture and the leading end of the insertion device extend out of themuscle at the orifice of the sac. Then the first pointed end of thesuture and the leading end of the endoscopic insertion device areinserted through an opposing side of the orifice, and are pushed throughthe muscle until the second axial location is proximate to a central tothe point of the orifice. The insertion device is gripped and pulled atthe trailing end to remove the insertion device, leaving the suture inplace. Optionally, the above steps may be repeated with additionalsutures. The muscle on the two sides of the orifice is advanced togetheras necessary to close the orifice.

A method is provided for joining and holding closed ulcerative lesionsor post-procedural tissue defects on an interior surface of a viscus,using an endoscopic insertion device as described above. The methodcomprises the step of inserting the first pointed end of the suture andthe leading end of the endoscopic insertion device through an entrypoint in the tissue spaced from and on one side of the lesion. Then thefirst end of the suture and leading end of the insertion device arepushed through the tissue until the first end of the suture and theleading end of the insertion device extend out of the tissue at thelesion. The first pointed end of the suture and the leading end of theendoscopic insertion device are then inserted through an opposing sideof the lesion, and are pushed until the second axial location isproximate to a central to the point of the lesion. The insertion deviceis gripped and pulled at the trailing end to remove the insertiondevice, leaving the suture in place. Again, optionally the above stepsmay be repeated. The tissue on the two sides of the lesion is advancedtogether to close the lesion.

In another embodiment, a method is provided for joining and holdingclosed a wound in urinary bladder muscularis tissue, using needles. Thefirst pointed end of the suture is inserted into the tissue below thesurface of the tissue at a first face of the wound at an initial point,which may for example be adjacent to one end or longitudinally spacedfrom both ends of the wound. The first end of the suture is pushedthrough the tissue along a curvilinear path until the first end of thesuture extends from the tissue at a subcutaneous exit point in the firstface of the wound and longitudinally spaced in a first direction fromthe insertion point in the first face of the wound. The first pointedend of the suture is gripped and pulled out of the tissue, drawing thefirst portion of the suture through the tissue until the second axiallocation is at the point of insertion of the first end in the first faceof the wound and leaving a length of the first portion of the suture inthe tissue of the wound. Then the first pointed end of the suture isinserted at a point below the surface of the tissue in a second face ofthe wound. The first end is pushed through the tissue along acurvilinear path until the first end extends from the tissue at an exitpoint in the second face of the wound below the surface of the tissueand longitudinally spaced in the first direction from the insertionpoint in the second face of the wound. The first end of the suture isinserted at a point in the first face of the wound below the surface ofthe tissue. The above steps are repeated starting with the insertion ofthe first end of the suture in the first face of the wound to advancelongitudinally along the wound in the first direction until reaching theend of the wound. Further, all of the above steps are repeated for thesecond end and second portion of the suture, in a second direction,starting with inserting the second end in the second face of the woundbelow the surface of the tissue and adjacent the initial point ofinsertion of the first end in the first face of the wound.

Another method is provided for joining and holding closed a wound inurinary bladder muscularis tissue, also using needles. The first pointedend of the suture is inserted into the muscularis tissue below thesurface of the tissue of a first face of the wound at an initial pointadjacent an end of the wound. The first end of the tissue is pushedthrough the tissue along a curvilinear path until the first end of thesuture extends from the tissue at an exit point in the first face of thewound below the surface of the tissue and longitudinally spaced from theend of the wound in a direction toward the other end of the wound. Thefirst pointed of the suture is gripped and pulled out of the tissue,drawing the first portion of the suture through the tissue until thesecond axial location is at the point of insertion of the first end inthe first face of the wound and leaving a length of the first portion ofthe suture in the tissue of the wound. The first end of the suture isthen inserted into the second face of the wound below the surface of thetissue. The first end of the suture is pushed through the tissue along acurvilinear path until the first end extends from the tissue at an exitpoint in the second face of the wound below the surface of the tissueand longitudinally spaced from the insertion point in the second face ofthe wound toward the other end of the wound. The first end of the sutureis inserted into the first face of the wound below the surface of thetissue, and the above steps are repeated starting with pushing the firstend through the tissue until extending from an exit point in the firstface of the wound, advancing longitudinally along the wound untilreaching the other end of the wound. The steps are repeated similarlyfor the second end and second portion of the suture, starting withinserting the second end of the suture into the tissue of the secondface of the wound below the surface adjacent the point of insertion ofthe first end.

An embodiment of a method is provided for joining a foreign element andbodily tissue, either of which may be referred to as first matter orsecond matter, using needles. The foreign element has a periphery andthe bodily tissue has a fibrous tissue ring with a face of the fibroustissue ring defining an opening and apposing a face of the periphery,and holding closed a junction between the element and the tissue. Thefirst pointed end of the suture is inserted into the periphery of theforeign element at a point radially spaced from the face of the fibroustissue ring. The first end of the suture is pushed through the peripheryuntil the first end of the suture extends out of the periphery at anexit point and penetrates the tissue of a face of the fibrous tissuering until the first end of the suture extends out of the tissue at anexit point radially spaced from the junction and spaced along thefibrous tissue ring circumference in a first direction from the point ofinsertion of the first end of the suture on the periphery. The first endof the suture is gripped and pulled, drawing the first portion of thesuture through the periphery and the tissue while bringing the peripheryand the tissue together to a closed position along the first portion ofthe suture. This continues until the second axial location is at thepoint of insertion of the first end of the suture in the periphery and alength of the first portion of the suture is left in the periphery andthe tissue between the point of insertion and the exit point. Then thefirst end of the suture is inserted into the tissue at the exit point ofthe first end. The first end is pushed through the tissue until thefirst end extends out of the tissue at an exit point in the face of thefibrous tissue ring and penetrates the periphery until the first endextends out of the periphery at an exit point radially spaced from thejunction and spaced along the circumference of the fibrous tissue ringin the first direction from the immediately preceding point of insertionof the first end of the suture in the periphery. The first end of thesuture is gripped and pulled out of the periphery, drawing the firstportion of the suture through the periphery and tissue while bringingthe periphery and the tissue together to a closed position along thefirst portion of the suture, and leaving a length of the first portionof the suture in the periphery between the point of insertion and theexit point. The above steps are repeated, with each repetition advancingthe suture around the circumference of the junction in a first directionFurther, the above steps are repeated similarly for a second end andsecond portion of the suture, in a second direction. In addition, asimilar method may be carried out with the suture first being insertedin the tissue rather than in the periphery of the foreign element. Thesutures may extend completely around the circumference of the junction,and may overlap one quarter or more of the circumference. Yet anotherembodiment provides that the suture enter and exit tissue on the face ofthe junction, and not exit on the surface of the foreign element or thetissue. Examples of applications of these methods include placement ofbioprosthetic heart valves, mechanical prosthetic heart valves, andbioprosthetics for cardiac septal defects.

Some embodiments include a method of mounting a device to bodily tissue,using needles. The device includes at least one eyelet for securing thedevice and through which a suture may pass. The method starts with thestep of placing the device in a desired position. Then a suture isthreaded through the eyelet. The first pointed end of the suture isinserted into tissue and is pushed through the tissue until extendingout an exit point. The first end of the suture is gripped and pulled outof the tissue while drawing the first portion of the suture through thetissue, leaving a portion of the suture between the first and secondaxial locations out of the tissue and leaving a length of the firstportion of the suture in the tissue between the point of insertion andexit point of the first end. These steps are repeated for the second endand portion of the suture in a second direction, resulting in the firstand second portions of the suture extending in the tissue in generallyopposing directions and causing the suture to resist displacement of thedevice. Examples of devices that may be mounted according to the presentinvention include catheters, electrodes of cardiac pacemakers, and tumormonitors. The device may be mounted internally, for example, to anorgan, or externally to the epidermis.

Further, methods of performing cosmetic surgery are provided. Oneembodiment of a procedure using needles begins with inserting the firstpointed end at an insertion point on the surface of a person's body. Thefirst end of the suture is pushed through soft tissue until the firstend extends out of the soft tissue at an exit point. The first end ofthe suture is gripped and pulled to draw the first portion of the suturethrough the soft tissue until the second axial location is proximate tothe point of insertion of the first end of the suture, leaving a lengthof the first portion of the suture in the soft tissue between the pointof insertion and exit point of the first end. The second pointed end ofthe suture is put in place by repeating these steps for the second endand second portion. The soft tissue is manually grouped and advancedalong at least one portion of the suture to provide the desired amountof lift.

Specific applications of cosmetic surgeries as described above include,for example, facelifts, browlifts, thigh lifts, and breast lifts. In anembodiment of a facelift, the insertion point is approximately at thetemporal hairline, and the first end of the suture is pushed throughsubepidermal tissue to the exit point of on the scalp. The second end ofthe suture is pushed through subepidermal tissue, the superficialmuscular aponeurotic system, or combinations thereof, to the exit pointproximate to the nasolabial fold. Tissue is manually grouped andadvanced along the second portion of the suture to provide the desiredamount of lift.

In an embodiment of a browlift, the insertion point is on a person'sface above the brow line. The first end of the suture is pushed throughsubepidermal tissue underneath the forehead, scalp, or both and the exitpoint of the first end of the suture is on the scalp. The second end ofthe suture is pushed through subepidermal tissue and the exit point ofthe second end of the suture is proximate to the brow. The tissue ismanually grouped and advanced along the second portion of the suture toprovide the desired amount of lift. The insertion may be approximatelyat the frontal hairline or the midpoint between the brow and frontalhairline.

Another embodiment of a browlift is provided for use with needles, andagain the insertion point is on a person's face above the brow line.Examples of insertion point locations for browlifts includeapproximately at the frontal hairline or halfway between the brow andthe frontal hairline. The first end of the suture is pushed throughsubepidermal tissue and the exit point of the first end of the suture isproximate to the brow. The second end of the suture is pushed throughsubepidermal tissue and the exit point of the second end of the sutureis proximate to the brow and spaced from the exit point of the first endof the suture. Then the tissue is manually grouped and advanced alongthe first and second portions of the suture to provide the desiredamount of lift.

An embodiment of a thigh lift is also provided. For a thigh lift, theinsertion point is generally at the inguinal crease. The first end ofthe suture is pushed cranially through subepidermal tissue until thefirst end of the suture extends out of the tissue. The second end of thesuture is pushed caudally through subepidermal tissue until the secondend of the suture extends out of the tissue on the thigh, and thentissues are manually grouped and lifted as desired.

Further, a method of performing a cosmetic breast lift is provided. Theinsertion point is at the upper aspect of the breast curvature, and thefirst end of the suture is pushed through subcutaneous tissue, dermaltissue, and pectoralis muscle until extending out of the tissue at anexit point on the upper portion of the breast. The second end of thesuture is pushed caudally through fibrous and fatty tissues until thesecond end of the suture extends out of the tissue at an exit pointalong the anterior aspect or the lower curvature of the breast, and thetissue is manually grouped and lifted as desired.

Embodiments of cosmetic surgery using an insertion device are alsoprovided. In these methods, the first pointed end of the suture and theleading end of the insertion device are inserted at an insertion point.The first end of the suture and the leading end of the insertion deviceare pushed through tissue beneath the epidermis until reaching anendpoint. Then the insertion device is gripped and pulled at thetrailing end to remove the insertion device, leaving the suture inplace, and the tissue is manually grouped and advanced along the firstportion of the suture to provide the desired amount of lift. This methodapplies, for example, to a facelift, where the insertion point is in thescalp distal from the temporal hairline. The suture is pushed throughthe reticular dermis underneath the scalp, and the first end of thesuture passes through the temporal hairline, penetrates the facialtissue such as the reticular dermis, the superficial muscularaponeurotic system, or a combination thereof, extending to thenasolobial fold. The method also applies to browlifts, where, forexample, the insertion point is in the scalp at a point distal from thefrontal hairline; and the suture is pushed through the reticular dermisunderneath the scalp until the first end of the suture passes throughthe frontal hairline, extending to be proximate to the browline.

Other embodiments are provided for a method for joining and holdingclosed an axial wound in a blood vessel such as an artery or vein, usingan insertion device. The first pointed end of the suture and the leadingend of the insertion device are inserted through an entry point in thetissue spaced from and on one side of the wound. The first end of thesuture and leading end of the insertion device are pushed through thetissue until penetrating the blood vessel wall on one side of the wound,continuing until extending into the interior of the blood vessel. Thefirst end of the suture and leading end of the insertion device are thenpushed through the interior of the blood vessel until the first end ofthe suture and the leading end of the insertion device penetrate theblood vessel wall on the other side of the wound, continuing through theblood vessel wall and penetrating the tissue on the other side of thewound. The first end of the suture and leading end of the insertiondevice are pushed through the tissue. In one embodiment, the secondaxial location is disposed in the blood vessel wall on one side of thewound and the first axial location is disposed in the blood vessel wallon the other side of the wound, resulting in no barbs being disposed inthe interior of the blood vessel. The insertion device is gripped andpulled at the trailing end for removal, leaving the suture in place, andthe tissue may be advanced on the two sides of the wound together asnecessary to close the wound.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the present invention, referenceshould now be had to the embodiments shown in the accompanying drawingsand described below. In the drawings:

FIG. 1 is a perspective view of an embodiment of a barbed suture withstraight pointed ends for use according to the methods of the presentinvention;

FIG. 2 is a perspective view of a barbed suture with curved pointed endsfor use according to the methods of the present invention;

FIGS. 3-6 are plan views of an embodiment of a method according to thepresent invention for joining two sides of an open wound in tissue;

FIGS. 7-10 are perspective views of another embodiment of a methodaccording to the present invention for joining two sides of an openwound in tissue;

FIG. 11 is a perspective view of a prior art method for joining twosides of an open wound in tissue using a spiraling suture path;

FIGS. 12-15 are perspective views of an embodiment of a method accordingto the present invention for joining two sides of an open wound intissue using a spiraling suture path;

FIGS. 16-18 are perspective views of still another embodiment of amethod according to the present invention for joining two sides of anopen wound in tissue;

FIGS. 19 and 20 are plan views of a further embodiment of a methodaccording to the present invention for joining two sides of an openwound in tissue;

FIG. 21 is a plan view of the embodiment shown in FIGS. 19 and 20 foruse in closing a vascular puncture via cinching of tissues directlyabove the vessel;

FIG. 22 is a cross-sectional view of the method shown in FIG. 21;

FIG. 23 is a side elevation view of a finger with a portion of the outerlayer of tissue cut-away to schematically show a severed tendon;

FIG. 24 is a plan view of the Kessler method for joining two ends of asevered tendon;

FIGS. 25-28 are perspective views of an embodiment of a method accordingto the present invention for joining two ends of a severed tendon;

FIGS. 29-30 are side elevation views of an embodiment of the methodaccording to the present invention for performing a Nissenfundoplication;

FIG. 31 is another embodiment of a method according to the presentinvention for performing a Nissen fundoplication;

FIGS. 32-34 are cut-away perspective views of an embodiment of themethod according to the present invention for laparoscopic insertion;

FIGS. 35-37 are perspective views of two embodiments according to amethod of the present invention for performing an anastomosis of a liverbile duct to a portion of a bowel;

FIGS. 38-39 are perspective views of an embodiment of the methodaccording to the present invention for performing an appendectomy;

FIGS. 40-42 are vertical cross-section views of an embodiment of themethod according to the present invention for performing a Zenker'sDiverticulectomy;

FIGS. 43-44 are partially sectioned perspective views of an embodimentof the method according to the present invention for closure ofulcerative intestinal lesions or other bowel wall defects;

FIG. 45-46 are front elevation views of two embodiments of the methodaccording to the present invention for closure of a cystostomy incisionin the urinary bladder;

FIG. 47 is a front elevation view of an embodiment of the methodaccording to the present invention for securing prosthetic heart valves;

FIG. 48 is a front elevation view of an embodiment of the methodaccording to the present invention for securing a catheter in position;

FIG. 49 is a perspective view of embodiments of the method according tothe present invention for performing cosmetic surgery;

FIGS. 50-52 are cross-section views of an axial wound closure in a bloodvessel according to two embodiments of the present invention.

DESCRIPTION

As used herein, the term “wound” means a surgical incision, cut,laceration, severed tissue or accidental wound in human skin or otherbodily tissue, or other condition where suturing, stapling, or the useof another tissue connecting device might be required.

As used herein, the term “tissue” includes tissues such as skin, bone,muscle, organs, and other soft tissue such as tendons, ligaments andmuscle.

Certain other terminology is used herein for convenience only and is notto be taken as a limitation on the invention. For example, words such as“upper,” “lower,” “left,” “right,” “horizontal,” “vertical,” “upward,”and “downward” merely describe the configuration shown in the figures.It is understood that the components may be oriented in any directionand the terminology, therefore, should be understood as encompassingsuch variations unless specified otherwise.

Referring now to the drawings, wherein like reference numerals designatecorresponding or similar elements throughout the several views, there isshown in FIGS. 1 and 2 a suture for use according to the presentinvention and generally designated at 40. The suture 40 includes anelongated body 42 having a plurality of barbs 44 disposed along thelength of the body 42. First and second ends 46, 48 of the body 42terminate in points 50, 52 for penetrating tissue.

The body 42 of the suture 40 is, in one embodiment, circular in crosssection. Suitable diameters for the body 42 of the suture 40 range fromabout 0.001 mm to about 1.0 mm. The body 42 of the suture 40 could alsohave a non-circular cross-sectional shape which would increase thesurface area of the body 42 and facilitate the formation of multiplebarbs 44.

The length of the suture 40 can vary depending on several factors suchas the extent of the wound to be closed, the type of tissue to bejoined, the location of the wound, and the like. A suture 40 of properlength is selected for achieving suitable results in a particularapplication.

Material for the body 42 of the suture 40 is available in a wide varietyof monofilament suture material. The particular suture material chosendepends on the strength and flexibility requirements. In one embodiment,the material for the body 42 is flexible and substantially nonresilientso that the shape of an inserted suture 40 will be determined by thepath of insertion and the surrounding tissue. In some applications,however, it may be desirable for at least a portion of the body 42 tohave sufficient dimensional stability to assume a substantially rigidconfiguration during use and sufficient resiliency to return to apredetermined position after deflection therefrom. The portions of theends 46, 48 of the suture 40 adjacent the points 50, 52 may be formed ofa material sufficiently stiff to enable the points 50, 52 to penetratetissue in which the suture 40 is used when a substantially axial forceis applied to the body 42. Variations in surface texture of the body 42of the suture 40 can impart different interaction characteristics withtissues.

The body 42 can be formed of a bioabsorbable material which allows thesuture 40 to be absorbed over time into the tissue as the wound heals.Bioabsorbable material is particularly useful in arthroscopic surgeryand methods of suturing. Many compositions useful as bioabsorbablematerials can be used to make the body 42 of the suture 40 for use inthe methods of the present invention. Generally, bioabsorbable materialsare thermoplastic polymers. Selection of the particular material isdetermined by the desired absorption or degradation time period whichdepends upon the anticipated healing time for the subject of theprocedure. Biodegradable polymers and co-polymers range in degradationtime from about one month to over twenty-four months. They include, butare not limited to, polydioxanone, polylactide, polyglycolide,polycaprolactone, and copolymers thereof. Other copolymers withtrimethylene carbonate can also be used. Examples are PDS II(polydioxanone), Maxon (copolymer of 67% glycolide and 33% trimethylenecarbonate), and Monocryl (copolymer of 75% glycolide and 25%caprolactone). Germicides can also be incorporated into the body 42 ofthe suture 40 which are retained by the suture 40 to provide longlasting germicidal properties.

The body 42 of the suture 40 can also be formed from non-absorbablematerial such as nylon, polyethylene terephthalate (polyester),polypropylene, and expanded polytetrafluoroethylene (ePTFE).Alternatively, the suture body 42 can also be formed of metal (e.g.steel), metal alloys, plastic, or the like.

The plurality of barbs 44 is axially-spaced along the body 42 of thesuture 40. The barbs 44 are oriented in one direction facing toward thefirst end 46 of the suture 40 for a first portion 54 of the length ofthe suture and in an opposite direction facing the second end 48 of thesuture 40 for a second portion 56 of the suture. The barbs 44 areyieldable toward the body 42. The barbs 44 on each portion 54, 56 of thesuture are oriented so as to allow movement of the suture 40 through thetissue in one direction along with the corresponding end 46, 48 of thesuture 40. The barbs 44 are generally rigid in an opposite direction toprevent the suture 40 from moving in the tissue in the oppositedirection.

The barbs 44 can be arranged in any suitable pattern, for example, in ahelical pattern as shown in FIGS. 1 and 2. The number, configuration,spacing and surface area of the barbs 44 can vary depending upon thetissue in which the suture 40 is used, and depending on the compositionand geometry of the suture body. The proportions of the barbs 44 mayremain relatively constant while the overall length of the barbs 44 andthe spacing of the barbs 44 are determined by the tissue beingconnected. For example, if the suture 40 is intended to be used toconnect the edges of a wound in skin or tendon, the barbs 44 can be maderelatively short and more rigid to facilitate entry into this ratherfirm tissue. If the suture 40 is intended for use in fatty tissue, whichis relatively soft, the barbs 44 can be made longer and spaced fartherapart to increase the holding ability in the soft tissue. Moreover, theratio of the number of barbs 44 on the first portion 54 of the suture 40to the number of barbs 44 on the second portion 56, and the lengths ofeach portion 54, 56, can vary depending on the application and needs.

The surface area of the barbs 44 can also vary. For example,fuller-tipped barbs 44 can be made of varying sizes designed forspecific surgical applications. For joining fat and relatively softtissues, larger barbs 44 are desired, whereas smaller barbs 44 are moresuited for collagen-dense tissues. There are also situations where acombination of large and small barbs 44 within the same structure willbe beneficial such as when a suture 40 is used in tissue repair withdiffering layer structures. Use of the combination of large and smallbarbs 44 with the same suture 40 wherein barb 44 sizes are customizedfor each tissue layer will ensure maximum anchoring properties.

The barbs 44 may be formed on the surface of the body 42 according toany suitable method, including cutting, molding, and the like. Thepreferred method is cutting with acute angular cuts directly into thesuture body 42 with cut portions pushed outwardly and separated from thebody 42 of the suture 40. The depth of the barbs 44 formed in the suturebody 42 depends on the diameter of the suture material and the depth ofcut. A particularly suitable device for cutting a plurality of axiallyspaced barbs 44 on the exterior of suture filaments utilizes a cuttingbed, a cutting bed vise, a cutting template, and a blade assembly toperform the cutting. When operated, the cutting device has the abilityto produce a plurality of axially spaced barbs 44 in the same or randomconfiguration and at different angles in relation to each other. Variousother suitable methods of cutting the barbs 44 have been proposedincluding the use of a laser. The barbs 44 could also be cut manually.However, manually cutting the barbs 44 is labor intensive, decreasesconsistency, and is not cost effective. The suture 40 could also beformed by injection molding, extrusion, stamping and the like. Thesuture 40 can be packaged in any number of desired pre-cut lengths andin pre-shaped curves.

The ends 46, 48 of the suture 40 may be straight (FIG. 1) or curved(FIG. 2). In one embodiment, the ends 46, 48 of the suture 40 may besurgical needles secured at each end of the body 42 of the suture 40 sothat the body 42 extends between the shank ends of the two needles. Theneedles are preferably constructed of stainless steel or other surgicalgrade metal alloy. The needles may be secured to the suture body 42 bymeans of adhesives, crimping, swaging, or the like, or the joint may beformed by heat shrinkable tubing. A detachable connection may also beemployed such that the needles may be removed from the body 42 of thesuture 40 by a sharp tug or pull or by cutting. The length of theneedles is selected to serve the type of tissue being repaired so thatthe needles can be completely removed leaving the suture body 42 in thedesired position within the tissue.

Barbed sutures suitable for use according to the methods of the presentinvention are described in U.S. Pat. No. 5,342,376, entitled “InsertingDevice for a Barbed Tissue Connector”, U.S. Pat. No. 6,241,747, entitled“Barbed Bodily Tissue Connector”, and U.S. Pat. No. 5,931,855. Thecontents of U.S. Pat. No. 5,342,376, U.S. Pat. No. 6,241,747, and U.S.Pat. No. 5,931,855 are hereby incorporated by reference.

According to the present invention, a surgical procedure using barbedsutures 40 is provided for binding together living tissue for healingand regrowth or reconfiguration in vivo. In general, when the suture 40is used in tissue to repair a wound, the suture is passed through tissueat each of the sides of the wound. The point 50 at one end 46 of thesuture 40 is inserted into a first side of a wound such that the point50 pierces the tissue and the barbs 44 on the end portion 54 of thesuture 40 corresponding to the one end 46 yield toward the body 42 tofacilitate movement of the suture 40 through the tissue in the directionof insertion. The other end 48 of the suture 40 is also inserted into aside of the wound and advanced through the tissue in like manner. Thesides or faces of the wound are then moved together along the sutureportions 54, 56 within the tissue to close the wound. The barbs 44 ofthe suture 40 grasp the surrounding tissue on each side of the wound andmaintains the edges of the wound in position during healing. The leadingends 46, 48 of the suture 40 protruding from the tissue are then cut anddiscarded. In one embodiment, ends of the suture 40 in the tissue aremade to lie below the surface of the skin by first depressing the skinimmediately around the ends and severing the suture body 42 closelyagainst the skin. The skin will rise to cover the ends of the suture 40.

FIGS. 3-6 show a section of tissue including a portion of a patient'sskin 58 and subcutaneous tissue defining a wound 60 from the surface ofthe skin 58 down into the tissue. It is understood that the wound 60 inthe tissue can be of any configuration and from any anatomical part ororgan of the body. Accordingly, depending on the configuration of thewound, the wound may comprise several sides and faces. However, thewounds depicted in the figures are straight incisions in the skin 58 toreduce the complexity of the description of the method of the presentinvention. It is understood that the applicants do not intend to limitthe method of the present invention to the closure of only straightincisions.

In this embodiment of the method of the present invention, the user,such as a surgeon, selects a suture 40 of sufficient length and havingstraight ends 46, 48. As noted above, in one embodiment, the ends 46, 48may be surgical needles.

Referring to FIG. 3, the surgeon inserts the needle 46 at the end of thefirst portion 54 of the suture 40 into the tissue at a point 62 on afirst side 64 of the wound 60 and laterally spaced from the face 66 ofthe wound 60 at the first side 64. The surgeon advances the needle 46along a selected substantially straight path through the tissue toextend out of the tissue at a subcutaneous point (not shown) in thefirst face 66 of the wound 60 and subcutaneously penetrating a point(not shown) in a face 68 of a second side 70 of the wound 60. Thesurgeon continues to advance the needle 46 through the tissue until thepoint 50 of the needle emerges from the tissue at a distal end of theselected path at an exit point 72 on the second side 70 of the wound 60.The exit point is laterally spaced from the face 68 of the second side70 of the wound and longitudinally spaced in a first direction from thepoint of insertion 62 at the first side 64 of the wound 60. The surgeongrips the exposed portion of the needle 46 and pulls the needle 46 outof the tissue. This action draws the first portion 54 of the suture 40having barbs 44 for resisting movement in the opposite direction throughthe tissue until the barbs 44 on the second portion 56 engage thesurface of the skin 58 at the insertion point 62 preventing furtheradvancement of the suture 40 through the tissue. A length of the firstportion 54 of the suture body 42 is thus positioned in the tissue alongthe selected path. The faces 66, 68 of the wound 60 are approximated bypushing the adjacent sides 64, 70 of the tissue together along the firstportion 54 of the body 42 of the suture 40 in the tissue.

The needle 46 is next inserted into the tissue at the exit point 72 andadvanced along a substantially straight path through the tissue toextend out of the tissue at a subcutaneous point 74 in the second face68 of the wound 60 and subcutaneously penetrating a point 76 in thefirst face 66 of the wound 60. The surgeon continues to advance theneedle 46 through the tissue until the point end 50 emerges from thetissue at a distal end of the selected path at an exit point 78 on thefirst side 64 of the wound 60 that is laterally spaced from the firstface 66 and longitudinally spaced in the first direction from the pointof insertion 72 at the second side 70 of the wound 60. Again the surgeongrips the exposed portion of the needle 46 and pulls the needle 46 outof the tissue, drawing the first portion 54 of the suture 40 through thetissue.

The previous steps are repeated with the first portion 54 of the suture40 by inserting the needle 46 into the exit point 78 on the first side64 of the wound 60 for advancing longitudinally in the first directionalong the wound 60 in a “zigzag” pattern as shown in FIG. 4. The numberof passes of the needle 46 is chosen in accordance with the size of thewound 60 and the strength required to hold the wound closed. Theremaining length of the first portion 54 of the suture 40 protrudingfrom the tissue at a first end 80 of the wound 60 is cut and discarded,leaving the remaining first portion 54 of the suture 40 in the tissue.The faces 66, 68 of the wound 60 are approximated by pushing theadjacent sides 64, 70 of the tissue together along the body 42 of thesuture 40 in the tissue.

It is understood that the step of approximating the sides 64, 70 of thewound 60 can be performed as the suture 40 is advanced or after the end80 of the wound 60 is reached. Moreover, we do not intend to limitourselves to the depth of the suture paths shown in the FIGs. as thedepth of the suture paths may be determined by the surgeon or the woundto be closed. Further, it is understood that straight ends 46, 48 of thesuture may also produce more curved transitions as determined by thesurgeon.

The surgeon repeats the steps of this procedure with the second needle48 on the second portion 56 of the suture (FIG. 5). The initialinsertion point 62 of the second needle 48 is at the same initial pointof insertion 62 of the first needle 46 at the first side 64 of the wound60. The surgeon thus advances the second portion 56 of the suture 40into the tissue along the wound 60 in a direction toward the other end82 of the wound 60 using the same zigzag pattern approximating the faces66, 68 of the wound 60. The remaining length of the second portion 56 ofthe suture 40 protruding from the skin 58 at the end 82 of the wound 60is then cut and discarded (FIG. 6).

An embodiment of the method for joining the sides of an open wound intissue according to the present invention using a subcuticular stitch isshown in FIGS. 7-10. The tissue shown in the figures includes anepidermis 84, dermis 86, fat 88, fascia 90 and muscle 92. By penetratingthe subcutaneous layers only and not the outer skin 58 layer, a wound 60can be closed to facilitate healing while minimizing scar tissue.

Referring to FIG. 7, the subcuticular stitch method of the presentinvention uses a barbed suture 40 including curved ends 46, 48. Thesurgeon begins by inserting the first needle 46 into the tissue belowthe skin 58 surface at a face 66 on a first side 64 of the wound 60 atan initial insertion point 63 longitudinally spaced from the ends 80, 82of the wound 60. The surgeon advances the needle 46 through the tissuealong a curvilinear path until the point 50 of the needle 46 extendsfrom the tissue at a subcutaneous exit point 73 in the first face 66 ofthe wound 60 longitudinally spaced toward one end 80 of the wound fromthe entry point 63 of the needle 46. The surgeon grips the needle 46 andpulls the needle 46 out of the tissue, drawing the first portion 54 ofthe suture 40 through the tissue until the barbs 44 on the secondportion 56 engage the tissue at the insertion point 63 preventingfurther advancement of the suture 40 through the tissue. A length of thefirst portion 54 of the suture body 42 is thus positioned in the tissuealong the selected curvilinear path as seen in FIG. 7.

Turning to FIG. 8, the surgeon then inserts the needle 46 into thetissue at a subcutaneous entry point (not shown) in the face 68 at thesecond side 70 of the wound 60. The surgeon repeats the above steps ofpushing the needle 46 through the tissue along a selected curvilinearpath so that the point 50 of the needle 46 emerges from a subcutaneousexit point (not shown) in the second face 68 of the wound 60longitudinally spaced toward the end 80 of the wound 60 from the entrypoint. The surgeon grips the needle 46 and draws the first portion 54 ofthe suture 40 into the tissue further along the wound 60. In thismanner, the surgeon advances the first portion 54 of the suture 40longitudinally along the wound 60 to the one end 80 of the wound in awave-like or “sinusoidal” pattern. As noted above, the faces 66, 68 ofthe wound 60 are approximated as the surgeon progresses, or when the end80 of the wound 60 is reached, by pushing the adjacent sides 64, 70 ofthe tissue together along the body 42 of the suture 40. The needle 46along with remaining length of the first portion 54 of the suture 40 isdrawn through the surface of the skin 58 at the one end 80 of the wound60 is cut and discarded (FIG. 8).

The surgeon repeats the procedure at the other end of the wound (FIG. 9)with the second portion 56 of the suture 40. The surgeon begins byinserting the second needle 48 into the tissue at a subcutaneous point(not shown) in the second face 68 of the wound 60. The surgeon advancesthe second needle 48 along a curvilinear path from the point of initialinsertion toward the other end 82 of the wound 60 until the needle 48emerges from a subcutaneous exit point (not shown) the second face 68 ofthe wound 60 longitudinally spaced from the initial entry point of theneedle 48. The surgeon then pulls the needle 48 from the tissue, drawingthe second portion 56 of the suture 40 into the tissue, and inserts theneedle 48 into the first face 66 of the wound 60 at a subcutaneous entrypoint (not shown) at the first side 64 of the wound 60. Again, thesurgeon advances the needle 48 along a curvilinear path until the needle48 emerges from a subcutaneous exit point 98 in the face 66 furthertoward the other end 82 of the wound and draws the needle 48 and sutureportion 56 through the tissue. FIG. 9 shows the needle 48 being drawn asecond time from the second face 68 of the wound 60. Thus, the surgeonadvances the second portion 56 of the suture in a sinusoidal pattern tothe end 82 of the wound 60 (FIG. 10) and approximates the faces 66, 68of the wound 60. The length of the second portion 56 of the suture body42 protruding from the skin 58 at the end of the wound 60 is then cutand discarded.

FIG. 11 shows a prior art subcutaneous suturing method for closing awound 60 using a spiraling, “corkscrew-shaped” stitch pattern. Thesurgeon begins at one end 80 of the wound by tying a knot 100 in thefirst loop and advancing the suture in a corkscrew pattern to the otherend of the wound 82 where the suture is tied off. Tying the knots at theend and burying them, which is preferred by the surgeon, is technicallyvery challenging, even more so when the incision is almost closed.

FIGS. 12-15 show a similar corkscrew-shaped stitch pattern for closing awound 60 according to an embodiment of the method of the presentinvention. This embodiment is similar to the method described aboveusing a subcutaneous sinusoidal stitch pattern.

Referring to FIG. 12, the surgeon begins by inserting one of the needles46 into the tissue below the skin 58 surface at a face 66 on a firstside 64 of the wound 60 at an initial subcutaneous insertion point 63longitudinally spaced from the ends 80, 82 of the wound 60. The surgeonadvances the needle 46 upward through the tissue along a curvilinearpath until the point 50 of the needle 46 extends from the tissue at asubcutaneous exit point 73 in the first face 66 of the wound 60longitudinally spaced toward one end 80 of the wound and above the entrypoint 63 of the needle 46. The surgeon then inserts the needle 46 intothe tissue at a subcutaneous entry point 102 in the face 68 at thesecond side 70 of the wound 60. The surgeon pushes the needle 46 throughthe tissue along a selected curvilinear path so that the point 50 of theneedle 46 emerges from a subcutaneous exit point 104 in the second face68 of the wound 60 longitudinally spaced toward the end 80 of the wound60 and below the entry point 102. The surgeon repeats these steps (FIG.13) for advancing the first portion 54 of the suture 40 longitudinallyalong the wound 60 to the one end 80 of the wound in the spiraling,corkscrew stitch pattern. It is understood that the number and diameterof coils can be varied as desired. At any selected convenient point, thesurgeon grips the needle 46 for drawing the first portion 54 of thesuture 40 through the tissue until the barbs 44 on the second portion 56engage the tissue at the insertion point 63 preventing furtheradvancement of the suture 40 through the tissue. The surgeonapproximates the faces 66, 68 of the wound 60 as the surgeon progressesor when the end 80 of the wound 60 is reached as described above. Theremaining length of the first portion 54 of the suture 40 is drawnthrough the surface of the skin 58 at the one end 80 of the wound 60 andcut and discarded.

The surgeon repeats the procedure at the other end 82 of the wound 60with the second portion 56 of the suture 40. As seen in FIG. 14, several“coils” of the second portion 56 of the suture 40 have been entered intothe tissue in a direction toward the other end 82 of the wound 60.Subcutaneous entry points 106 and exit points 108 in the faces 66, 68 ofthe wound 60 are visible. The surgeon advances the second portion 56 ofthe suture 40 to the end 82 of the wound 60 (FIG. 15) and approximatesthe faces 66, 68 of the wound 60. The length of the second portion 56 ofthe suture body 42 protruding from the skin 58 at the end of the wound60 is then cut and discarded.

Another embodiment of a subcutaneous suturing method for joining andholding closed an open wound 60 in tissue according to the presentinvention is shown in FIGS. 16-18. This method also uses a barbed suture40 having curved pointed ends 46, 48, such as surgical needles.

Referring to FIG. 16, the surgeon begins by inserting the first needle46 subcutaneously into the tissue at a face 66 on a first side 64 of thewound 60 at an initial insertion point 63 adjacent one end 80 of thewound 60 and pushes the needle 46 through the tissue along a selectedcurvilinear path until the needle 46 extends from the tissue at asubcutaneous exit point 73 in the first face 66 of the wound 60longitudinally spaced from the end 80 of the wound 60 in a directiontoward the other end 82 of the wound 60. The surgeon grips the needle 46and pulls the needle 46 out of the tissue for drawing the first portion54 of the suture 40 including barbs 44 for resisting movement in theopposite direction through the tissue until the barbs 44 of the secondportion 56 engage the first face 66 of the wound 60 at the insertionpoint 63 preventing further advancement of the suture 40 into thetissue. A length of the first portion 54 of the suture body 42 is thuspositioned in the tissue along the selected curvilinear path.

As further seen in FIG. 16, the surgeon next inserts the second surgicalneedle 48 into the tissue at a subcutaneous entry point (not shown) inthe face 68 at the second side 70 of the wound 60 substantially oppositethe initial point of insertion 63 of the first needle 46 at the one end80 of the wound 60. The surgeon advances the second needle 48 throughthe tissue along a selected curvilinear path until the needle 48 extendsfrom the tissue at a subcutaneous exit point (not shown) in the secondface 68 of the wound 60. The surgeon then pulls the second needle 48 fordrawing the second portion 56 of the suture 40 through the tissue,including barbs 44 for resisting movement in the opposite direction,leaving a length of the second portion 56 of the suture 40 in the tissueat the end 80 of the wound 60.

The surgeon repeats the above steps with the first needle 46 and secondneedle 48 at the second and first sides 64, 70, respectively, of thewound 60. In this manner, the surgeon advances the suture 40longitudinally along the wound 60 from the one end 80 of the wound tothe other 82 in a “shoelace” pattern. As seen in FIG. 17, several passesof the suture 40 have been entered into the tissue of the wound 60. Thefaces 66, 68 of the wound 60 are approximated as the surgeon progresses,or when the end 82 of the wound 60 is reached, by pushing the adjacentsides 64, 70 of the tissue together along the body 42 of the suture 40.The lengths of the first portion 54 and second portion 56 of the suture40 protruding from the skin 58 are cut and discarded (FIG. 18).

It is understood that the method of the present invention shown in FIGS.7-10 can be used to generate a similar stitch pattern if a second sutureis used which is entered in the tissue to mirror the path of the firstsuture.

Another embodiment of the method according to the present invention forjoining the sides 64, 70 of tissue in an open wound 60 is shown in FIGS.19 and 20. In this embodiment, the surgeon inserts a first curved orstraight end 46 of the suture 40, such as a needle, into the tissue at apoint 62 on a first side 64 of the wound 60 and laterally spaced fromthe face 66 of the wound 60 at the first side 64. The surgeon advancesthe needle 46 through the tissue along a curvilinear path until theneedle 46 emerges from the tissue on a second side 70 of the wound at anexit point 72 laterally spaced from the face 68 of the second side 70 ofthe wound 60 and longitudinally spaced in a first direction from thepoint of insertion 62. This path subcutaneously passes through bothfaces 66, 68 of the wound 60. The surgeon grips the needle 46 and pullsthe needle 46 out of the tissue for drawing the first portion 56 of thesuture 40 through the tissue until the barbs 44 of the second portion 56engage the surface of the skin 58 at the insertion point 62 preventingfurther advancement of the suture 40 into the tissue. The faces 66, 68of the wound 60 are approximated by pushing the adjacent sides 64, 70 ofthe tissue together along the body 42 of the suture 40 in the tissue.The length of the first portion 54 of the body 42 of the suture 40protruding from the skin 58 is cut and discarded (FIG. 19).

The surgeon then inserts the second needle 48 into the tissue at thepoint of insertion 62 of the first needle 46 at the first side 64 of thewound 60. The surgeon pushes the needle 48 through the tissue along acurvilinear path which substantially mirrors the passage of the firstneedle 46 until the needle 48 emerges from the tissue at an exit point110 laterally spaced from the wound and longitudinally spaced in asecond direction from the point of insertion 62 such that the paths ofthe first and second portions 54, 56 of the suture 40 overlap. Again,the path of the second needle 48 subcutaneously passes through the faces66, 68 of the wound 60. The surgeon grips the second needle 48 and pullsthe needle 48 from the tissue for drawing the second portion 56 of thesuture 40 into the tissue. The length of the second portion 56 of thesuture 40 protruding from the skin 58 is cut and discarded, leaving astitch in the tissue which resembles the Greek letter alpha (FIG. 20).

This stitch has its greatest benefit in small wound and incisionclosure. The alpha-shaped stitch can be placed quickly in tissue ascompared with conventional loop sutures. Moreover, this stitch patternhas no blood constricting loops, leaves no stitch marks on the surfaceof the skin, and does not have to be removed from the patient ifbio-absorbable material is used. Two or more of the alpha-shapedstitches may be used to close a larger wound.

A particular application of the alpha-stitch according to the method ofthe present invention is as a means of restricting bleeding from anarterial opening by constricting the tissue above and around thearterial opening. For example, the introduction and removal of cathetersinto the femoral artery is typically required when performing cardiaccatheterization, percutaneous interventions, and other vascularprocedures. These puncture wounds are typically self-sealing afterseveral hours of sustained external pressure at and around the insertionsite of the puncture wound. FIGS. 21 and 22 show the alpha-stitchaccording to a method of the present invention positioned for performingthis function. Note that the path of the suture portions 54, 56 iscurvilinear with the respect to the skin 58 surface and that the deepestpoints of the arcs pass immediately above the puncture site 112 in theartery 114. In this embodiment, the ends 46, 48 of the suture 40 arepulled to put tension in the tissue. As the ends 46, 48 of the suture 40are pulled, the tissue embraced by the suture is pulled both inward fromthe areas lateral to the artery 114 and downward from areas immediatelyabove the artery 114. This constriction of tissue increases the densityof tissue around the arterial puncture site 112 and imparts forces withvectors directed toward the arteriotomy site to limit bleeding. Further,this suture method avoids the need to traverse the artery wall or lumen,thus eliminating the risk of vessel wall dissection and promotingintrogenic thrombogenesis.

The method of the present invention is also useful in binding togetherpartially or completely severed tendons or other internal tissue repairsrequiring considerable tensile strength. For example, referring to FIG.23, a finger 120 is shown with a portion of the outer layer of tissuecut-away to schematically show a severed tendon 122. A Kessler suturingmethod for joining the two ends 124, 126 of the tendon 122 is shown inFIG. 24. This method requires the surgeon to apply an intricate stitchpattern and to complete the tendon connection with one or twotechnically challenging knots 128. No portion of the suture knot 128 mayprotrude from the outside surface of the repaired tendon 122 where itcould snag the surrounding tendon sheath and impede healing. The knot128 also presents a particular dilemma since it must be tied between thetwo ends 124, 126 of the tendon 122, where it can be a barrier betweentendon sections that must appose in order to effectively heal. A furtherlimitation of the conventional tendon repair method is that relativelysmall amounts of tension can stretch the tendon 122, allowing it toslide along the smooth monofilament fiber and effectively disrupt, or inthe case of greater amounts of tension, separate completely at the woundmargin. This outcome substantially limits healing even though the suturematerial remains intact.

A method according to the present invention for joining the two ends124, 126 of the tendon 122 is shown in FIGS. 25-28. Referring to FIG.25, the surgeon begins by inserting the first end 46 of the suture 40,which may a straight or curved surgical needle, into one end 124 of thetendon 122 and pushing the needle 46 through the tendon 122 along aselected curvilinear path until the point 50 of the needle 46 extendsfrom an exit point 130 in the periphery of the tendon 122 longitudinallyspaced from the one end of the tendon 122. The first needle 46 isgripped and pulled out of the tendon for drawing the first portion 54 ofthe suture 40 through the tendon 122 leaving a length of the firstportion 54 of the suture in the tendon end 124 between the end of thetendon 122 and the exit point 130. The surgeon reinserts the needle 46into the periphery of the tendon 122 at an entry point 132 immediatelyadjacent the exit point 130 and pushes the needle 46 along a selectedcurvilinear path until the point 50 of the needle 46 exits the otherside of the tendon at an exit point 134 that is longitudinally spacedfrom the entry point 132. It is understood that the surgeon could usethe exit point 130 as the next entry point for the needle 46 if desired.The surgeon pulls the needle 46 out of the tendon for drawing the firstportion 54 of the suture 40 through the tendon 122, reinserts the needle46 into the side of the tendon 122 at an entry point 136 immediatelyadjacent the exit point 134 and pushes the needle 46 along a selectedcurvilinear path back out of the other side of the tendon 122 at an exitpoint 138 longitudinally spaced from the previous entry point 136. It isunderstood that the surgeon makes as many passes as deemed necessary forholding the end 124 of the tendon 122, or as the length or thickness ofthe tendon 122 allows, and removes the remaining length of the firstportion 54 of the suture 40.

As seen in FIG. 26, these steps are repeated with the second portion 56of the suture 40 at the other end 126 of the tendon 122. The pattern ofthe second portion 56 of the suture 40 in the second end 126 of thetendon 122 generally mirrors the first portion 54 of the suture 40 inthe first end 124 of the tendon 122, including exit points 130 a, 134 a,138 a and entry points 132 a, 136 a. The ends 124, 126 of the tendon 122are brought together while maintaining tension on the free ends of thesutures.

Referring now to FIG. 27, a second suture 40 a is introduced at thesecond end 126 of the tendon 122. The first needle 46 a of the secondsuture 40 a is inserted into the end 126 of the tendon 122 and pushedthrough the tendon 122 along a selected curvilinear path until theneedle 46 a extends from an exit point 140 in the periphery of thetendon 122 substantially opposite the first exit point 130 a of thesecond portion 56 of the first suture 40. The needle 46 a of the secondsuture 40 a is pulled out of the tendon 122 for drawing the firstportion 54 a of the second suture 40 a through the tendon 122 leaving alength of the suture 40 a in the tendon 122 between the end 126 of thetendon 122 and the exit point 140. The surgeon repeats the stepsdescribed above by reinserting the needle 46 a into the tendon 122 at anentry point 142 (FIG. 28) adjacent the exit point 140 and pushing theneedle 46 a along a selected curvilinear path until the needle 46 aemerges from an exit point 144 in the periphery of the tendon 122substantially opposite the second exit point 134 a of the second portion56 of the first suture 40. In this manner, the surgeon advanceslongitudinally along the end 126 of the tendon 122 entering at 146 andexiting at 148. The previous steps are repeated at the other end 124 ofthe tendon 122 with the second portion 56 a of the second suture 40 a.The number of sutures used depends on the size, caliber, and length ofthe tendon to be repaired. Big tendons will require more than twosutures whereas one may suffice for very small tendons.

Tendon repair with two sutures according to the present inventionexhibits equivalent or better holding power as the prior art technique.Moreover, tendons repaired according to the methods of the presentinvention maintain their original configuration, profile, contour, andform better when being stretched.

The method of the present invention may be embodied in many surgicalprocedures. The procedures include both “open” surgery as well asendoscopic and laparoscopic surgery. Further, the uses of embodiments ofthe present invention may include repair of wounds, fastening of tissuejunctions formed by the procedures, and positioning of tissue. Thesurgical procedures described herein are known to those of ordinaryskill in the art, and accordingly are described only to a level ofdetail required to convey the respective embodiments of the method ofthe present invention. In FIGS. 29-48, where various steps of insertionare omitted from a drawing, it should be understood that the descriptionand accompanying text of FIGS. 1-28 apply to inserting the sutures 40.

FIG. 29 shows a stomach 200 prior to performance of a Nissenfundoplication. This procedure is performed on patients who suffer fromgastroesophageal reflux disease and do not respond to medical treatment.As shown, the first portions 54 of two respective barbed sutures 40 areinserted into a proximal location of the fundus 202 and into the serosaland muscularis layers, and the respective second portions 56 remainfree. The stomach's fundus 202 is pulled behind and wrapped 206 aroundthe esophagus 204. The respective second portions 56 are then advancedsimilarly into the apposing part 208 of the stomach 200, as shown inFIG. 30.

The same result in fastening may be achieved by performing the procedurein a different order. The fundus 202 may be pulled and wrapped 206behind the esophagus 204 first, and then temporarily clamped or stapledin placed while the first and second portions 54, 56 are inserted in theconfiguration shown in FIG. 30. Other sequences may also be used andremain within the scope of the present invention.

The barbed suture 40 may also be inserted as shown in FIG. 31, in eithera sinusoidal or coiled configuration as previously described. The curvedinsertion is performed subsequent to pulling and wrapping 206 the fundus202 behind the esophagus 204, and then clamping or stapling in place.

FIG. 32 shows a laparoscopic insertion device 220 used to stabilize abowel structure 222 in position in advance of performing an anastomosis,whereby an end-to-end surgical connection of hollow organs isconventionally performed. The laparoscopic insertion device 220comprises a tubular body in which the barbed suture 50 is disposed, withholes at the leading and trailing ends, similar to that disclosed inU.S. Pat. No. 5,342,376 to Ruff, the contents of which were previouslyincorporated by reference herein. The insertion device 220 penetratesusing the point 50 of the suture to pierce the epidermis 84, dermis 86,fat 88, fascia 90, muscle 92, and the peritoneum 94 before passing intothe abdominal cavity 224. The insertion device 220 then passes into thebowel structure 222. A laparoscopic grasping tool 226 is shown to beholding the bowel structure in position until the suture is in place. Itshould be noted that the bowel structure 222 may also be stabilized byplacement of a barbed suture 40 from the inside of the structure 222.

In FIG. 33, the laparoscopic insertion device is removed by pulling itoutward 228, exposing the suture 40, while the pointed end 50 of thesuture 40 is retained by its barbs against the removal force of theinsertion device 220. The suture 40 is in place in FIG. 34. When theprocedure that gave rise to the need to tie the bowel structure 222 inplace is complete, the suture may be cut at an exposed point 229. Asshown, the trailing end of the suture 40 extends through the epidermis84 at the point of initial insertion, and the suture 40 may be cut atpoint 229 to allow that portion of the suture 40 to be removed bypulling on the trailing end.

Optionally, the barbed suture pointed end 50 may continue through thebowel structure 222 tissue, into the abdominal cavity 224, and throughany number of desired selected layers of the peritoneum 94, muscle 92,fascia 90, fat 88, dermis 86, and epidermis 84. If the suture 40 passesthrough the epidermis 84 and is to be left in place, the suture 40 my becut off such that the end of the suture 40 resides beneath the epidermis84. Alternatively, in a method similar to that described for FIG. 34,when the procedure that gave rise to the need to tie the bowel structure222 in place is complete, the suture 40 may be cut at the exposed point229 and in addition at another exposed point along the suture 40 on theopposite side of the bowel structure 222, allowing removal of both endsof the suture 40.

A portion of the biliary system is shown in FIG. 35. The liver 230 isshown in partial section view, and the gallbladder 232, bowel 234, andstomach 200 are the other organs that are shown. The barbed suture ofthe present invention may be used to perform a Rodney Smith procedurewith Roux-en-Y for the anastomosis of the bowel 234 to the liver 230. Insuch an operation, the bile duct 236 may be cut, for example, at point237 and anastomized to the bowel 234 at an incision in the bowel 234 atpoint 238. The sutures 40 may be inserted as shown in FIG. 36 witheither an insertion device or with needles as previously discussed. Theremaining portion of the bile duct 239 is removed and the wound at theend where it connects to the bowel 234 is sutured closed, which may alsobe done with sutures 40 of the present invention. In addition, barbedsutures can be placed in a curvilinear path, as shown in FIG. 37 byproceeding with the suture around the bile duct 236 and the opening inthe bowel. The first insertion point of the suture may be either in thebowel or the bile duct.

The appendix 240 is being removed from the cecum 242 of the largeintestine in FIG. 38. Prior to cutting of the appendix 240, the suture40 must be placed so that it will be ready to tie off the appendicealstump 244. The suture 40 may be placed using a curved insertion device(not shown), or with curved needles 46, 48. The barbed suture 40 isplaced around the base of the appendix 240 by inserting the first end ofthe first portion of the suture at an insertion point 62 (FIG. 39) andpushing the first portion 54 in one direction through the muscularis andserosal layers of the cecum 242 around the base for at least one half ofthe circumference. Then the second portion 56 is likewise placed byinserting at the insertion point 62 and pushing the second portion 56 inthe other direction through the muscularis and serosal layers of thececum 242 around the base for at least until the second portion 56crosses the first portion 54. The appendix 240 is then removed, and thestump 244 is inverted while the suture 40 is pulled taut, similar to a“purse-string” as well as the alpha stitch shown in FIGS. 19-22.

Although FIG. 38 shows both needles 50, 52 and respective suture endportions 54, 56 extending from the cecum 242, having both end portions54, 56 extend from the cecum 242 is optional. With the use of aninsertion device of the nature of that shown in FIG. 33, for example(device 220), one end may be left embedded in the cecum 242 and theother end may be pulled to invert the appendiceal stump 244 with thepurse-string or alpha stitch.

FIGS. 40-42 show three stages of the procedure for a Zenker'sDiverticulectomy. A Zenker's Diverticulum 260 is a sac that protrudesfrom the esophagus 262 below the pharynx 264. The Diverticulum 260 isthe herniation of the mucosal sac between the fibers of the pharyngealconstrictor muscle and the cricopharyngeal muscle 266. The Diverticulumforms an orifice 268 to the lumen 270 of the esophagus 262, and is shownin its initial untreated position in FIG. 40.

In FIG. 41 the Diverticulum 260 is inverted and pulled into theesophagus 262 through the orifice 268 using an endoscopic grasping tool272. An endoscopic insertion device 274, similar to the laparoscopicinsertion device 220 of FIGS. 32-34, is used as shown in FIG. 42 toinsert the barbed suture 40 into the cricopharyngeal muscle 266 abovethe orifice 268, exiting at the orifice, and then again penetrating themuscle 266. The muscle 266 on both sides of the orifice 268 isapproximated to close the orifice. The Diverticulum 260 is thenendoscopically cut and removed (not shown). Alternatively, the stitchused to close the orifice 268 may be a purse-string type or alpha type,as shown in FIGS. 38 and 39. Multiple sutures may be used to close theorifice. Further, the procedure of suturing closed the orifice may beperformed in a similar manner without inverting the Diverticulum 260into the esophagus 262. In this alternative the Diverticulum remainsoutside the esophagus 262 and is not excised.

The viscus structure 300 shown in FIGS. 43-44 has an ulcerative lesion302 on its inside wall 304. An endoscopic camera 306 (“scope”) allowsthe procedure to be performed, and an endoscopic insertion device (notshown) in a separate tube within the scope inserts the sutures 40 aspreviously described. The scope 306 may approach the lesion 302 throughthe anus or the oropharynx. The tissue on each side of the lesion 302 isapproximated and the endoscopic devices are removed as shown in FIG. 44.

FIGS. 45 and 46 respectively show a closure of a cystostomy incision ina urinary bladder 320. The closure is shown as having a curvilinearpath, and may be inserted in such a curvilinear path similarly to thesinusoidal method (FIG. 45) or coil method (FIG. 46) previouslydiscussed and shown by FIGS. 7-10 and FIGS. 12-15, respectively,although other methods discussed herein may also be used. The suture 40passes through the muscularis layer of the bladder in a bidirectionalfashion.

A replacement heart valve 340 is shown in FIG. 47. The annular cuff 342of the heart valve 340 forms the periphery of the valve. The cuff 342 isjoined to fibrous heart tissue 344 that forms a ring in the locationwhere the valve 340 is placed. Two sutures 40 a, 40 b are shown,respectively having first portions 54 a and 54 b that pass through thecuff 342 and tissue 344 in one direction and second portions 56 a and 56b that proceed in the other direction. Threading of the sutures 40 a, 40b is performed similarly to the sinusoidal and coil methods previouslydiscussed, and may start from either the cuff 342 or the tissue 344.

Various configurations may be used to install the valve 340 inaccordance with the knowledge of one of ordinary skill in the art, suchas only one suture for the full periphery of the valve, or multiplesutures that each include a portion of the valve's periphery, andproviding redundancy of sutures as appropriate. The replacement heartvalve may be a bioprosthetic valve or an artificial prostheticmechanical valve. In addition, this method may be used on any foreignelement that has a periphery and requires attachment to tissue, forexample, a patch for closing a septal defect in the heart.

The method according to the present invention may also be used to securedevices to tissue, both inside and outside of a body. A central linedevice 360, as used for intravenous access, is shown in FIG. 48, and isattached to a person's leg 362. Examples of other devices that arerequired to be secured include catheters and monitors; tumor monitors inparticular are an example of an internal device that may benefit fromthe method of the present invention. Eyelets 364 a, 364 b are providedon the device 360 and the suture 40 passes through each eyelet 364 a,364 b before penetrating and passing through tissue of the leg 362 in amanner similar to that previously described, and being pulled snug tosecure the device 360.

To facilitate removal of the barbed suture 40, the suture 40 may be cutat a point within the central portion 366, separating the portions ofthe suture 40 with opposing barbs. Then the separate sections 54, 56 ofthe suture 40 may be removed by pulling on an exposed portion in thedirection that the barbs allow movement of the suture 40 through thetissue. This method of removal is not limited to the use shown in FIG.48, but may apply to any use of the barbed suture.

The barbed sutures of the present invention may also be used in avariety of cosmetic surgery applications. Such applications include butare not limited to facelifts, browlifts, breast lifts, and thigh lifts.In each of the procedures, once the sutures are in place and as tensionis maintained on the free ends of the suture (not shown in the figuresreferenced below), the engaged tissues are manually grouped and advancedtoward the insertion point to achieve the desired lifting effect. Thetissue into which the sutures are inserted are soft tissue, meaning anytissue that is not an organ or a vessel. Multiple sutures may be usedfor further augmentation or maintenance of lift.

A facelift and two methods of browlifts are shown in FIG. 49. One end380 of a barbed suture 382 is inserted using a needle (not shown) at thetemporal hairline at point 384 and advanced through the subepidermaltissue underneath the scalp, exiting distally. Subepidermal tissuecomprises the papillary dermis, reticular dermis, subcutaneous tissue,or any combination thereof. The other end 386 is inserted at the samelocation and extended towards the nasolabial fold 388, engaging thesubepidermal tissue, the superficial muscular aponeurotic system, orboth, and exiting distally. As tension is maintained on the free ends(not shown) of the suture 382, the engaged tissues on the lower end 386are manually grouped and advanced toward the insertion point 384 toachieve the desired lifting effect. The procedure is repeated on theopposite side of the face. Similar procedures may be performed toprovide the lifts made in other locations with barbed sutures 390, 400.

In addition, the barbed sutures may be applied with the use of aninsertion device as previously discussed. For example, the barbedsutures 382, 390 shown in FIG. 49 may be put in place using an insertiondevice from either end of the respective suture.

One method of performing a browlift is shown with one end 408 of abarbed suture 410 being inserted at point 412 at the hairline (fornonreceding hairlines, as depicted) or at the midpoint between thehairline and the eyebrow (for receding hairlines, not shown). This end408 is advanced through the subepidermal tissue towards and on throughthe scalp. The other end 414 is inserted at the same point and advancedthrough the subepidermal tissue in the opposite direction, exiting atthe inferior aspect 416 of the brow. The procedure is repeated on theopposite side of the forehead, but for convenience herein a differentmethod is shown in the same figure. Once again, the suture 410 may beput in place with the use of an insertion device from either end.

A second method of performing a browlift is shown in FIG. 49 with oneend 420 of a barbed suture 422 being inserted at point 424 at thehairline (for nonreceding hairlines, as depicted) or between thehairline and the eyebrow (for receding hairlines, not shown). This end420 is advanced through the subepidermal tissue, exiting at the inferioraspect 426 of the brow. The other end 428 is inserted at the same pointand is also advanced through the subepidermal tissue, but at a slightangle to the path taken by the first end 420 and also exiting at theinferior aspect 426 of the brow. This results in the approximateinverted vee-shaped configuration shown. The procedure may be repeatedacross the forehead.

Barbed sutures of the present invention may similarly be used as atissue-sculpting device to perform a thigh or breast lifting procedure.These procedures are similar to those shown for the facelift andbrowlift of FIG. 49, and accordingly no additional drawings are requiredbut respective descriptions are as follows.

To perform a thigh lift, multiple sutures are inserted by needle at theinguinal crease, spaced approximately 0.5-1.5 cm apart, beginning at thelateral aspect of the pubic triangle and extending mediallyapproximately 180 degrees to the vicinity of the gluteal fold. Thesuture is advanced approximately 8 cm cranially through the subepidermaltissue. The opposite end of the suture is inserted in the same locationand similarly advanced approximately 8 cm caudally. After exitingthrough the skin distally at each end, tension is maintained on the freeends of the suture, and the engaged tissues are manually grouped andadvanced toward the insertion point to achieve the desired liftingeffect. The process is repeated with multiple sutures around thesemi-circumference of the thigh, and then repeated on the oppositethigh.

To perform a breast lift using a barbed suture of the present invention,one end of the barbed suture is inserted by needle into the skin at theupper aspect of the breast curvature. The needle is advanced such thatthe medial barbs engage the subcutaneous and dermal tissues, while thedistal barbs engage the pectoralis muscle (and where possible, theperiosteum of the clavicle), and then exit distally through the skin.The other end of the suture is inserted at the same point by needle, andadvanced caudally through the fibrous and fatty tissues of the breastexiting at various points along the lower curvature of the breast.Additional sutures are similarly inserted at a variety of appropriatelyspaced locations along the breast. As tension is maintained on the freesuture ends, the breast is lifted along the axis of the suture, with thebarbs locking the lift into place. Lifting is continued until thedesired effect is achieved. Results from such a procedure may benefitfrom the use of a barbed suture with longer barbs than may be necessaryin other procedures, in order to grasp fatty breast tissue effectively.

In FIG. 50, an insertion device 500 is shown in a procedure to close anaxial wound in a blood vessel, such as an artery or vein. The wound 112is similar to that shown in FIG. 22, but the method is different in thatthe method of FIG. 22 uses needles and does not penetrate the artery114, rather constricting the tissue above and around the arterialopening. The insertion device 500 of FIG. 50 comprises a tubular body inwhich the barbed suture 50 is disposed. The wound 112 may be a puncturein an artery 114 as occurs as the result of the introduction and removalof catheters, as discussed in the text accompanying FIG. 22. The sharppointed end 50 of the suture 40 is pushed with the leading end of theinsertion device 500 through the skin 58 and tissue 70 on one side ofthe artery 114, through the artery wall on one side of the wound 112,into the interior 504 of the blood vessel 114, through the artery wallon the other side of the wound 112, and into the tissue 64 on the otherside of the wound 112. The trailing end of the insertion device 500 isthen pulled on to remove the insertion device 500, leaving the suture 40in place.

Two embodiments of a suture left in place by an insertion device areshown in FIGS. 51 and 52. In FIG. 51, the portion 506 of the suture 40in the interior 504 of the artery 114 has barbs. The embodiment of FIG.52 omits barbs in the interior 504 of the artery 114, and the barbs areomitted for a portion 508 that extends into the artery 114 wall. Theportion 508 without barbs could extend less or more than shown, and intothe tissue 70, 64, so long as there are no barbs inside the artery 114.To reduce the chance of clotting of blood on or around the suture, anantithrombotic agent may be applied on the suture. Although FIGS. 50-51show the suture 40 with the pointed end 50 embedded in tissue 70, 64,the suture 40 may also be put into place with the pointed end 50, orboth ends, extending out of the skin 58, where the end or ends may becut.

The invention is further illustrated by the following non-limitingexamples.

EXAMPLE 1

A straight incision wound, about 1.5 cm deep, was created in each offour samples of cadaveric porcine skin tissue. The tissue samplesmeasured 4 cm by 10 cm. Each incision was centered on the skin sample sothat the wound was 4 cm long from end to end.

Each wound was closed according to a different suture method usingidentical barbed sutures made from monofilament PDS (polydioxanone) size0. One wound was closed according to the method shown in U.S. Pat. Nos.5,342,376 and 6,241,747, without using the inserting device (“the Ruffmethod”). Seven sutures were placed along the length of the wound andrunning generally perpendicularly to the faces of the wound. Whenplaced, the sutures dipped below the incision line thus engagingsubcutaneous tissue below the incision and the ends of the suturesengaged some dermis. A second wound was closed using seven needle-tippedsutures placed along the length of the wound in the dermis and runninggenerally perpendicularly to the faces of the wound similar to themethod shown in U.S. Pat. No. 5,931,855 (“the Buncke method”). In bothmethods, the length of each suture buried under the skin wasapproximately 6 cm. A third wound was closed using the “zigzag” stitchpattern in the dermis as described above and shown in FIGS. 3-6. Thenumber of passes resulted in four entry/exit points on each side of thewound. A fourth wound was closed using the corkscrew-shaped stitchpattern described above and shown in FIGS. 12-15. The number of passesresulted in seven complete loops with the tops of the loops engaged inthe dermis. The tissues were held together only by the sutures.

Biomechanical strength testing was carried out as follows. Each samplewas positioned so that the surface of the tissue sample wassubstantially vertical and the incision was generally horizontal. Thebottom edge of the sample was immovably secured. The upper edge of thesample was attached to a Berkley digital fish scale (0-50 lb.) The scalewas then raised vertically generating tension across the wound. Thescale was raised until the tissues totally separated. The peak forcerequired to separate the incision was recorded as the breaking strength.

TABLE 1 Breaking Strength Suture Method (lbs.) Ruff Method 4.5 BunckeMethod 8.5 Zigzag Method 18.3 Corkscrew Method 16.5

EXAMPLE 2

Seven incisions were made at various locations on each of three dogs.The length of the incisions ranged from ½ inch to 4 inches and the depthof the incisions from the dermis to the muscular level. The incisionswere closed with barbed sutures made from monofilament PDS(polydioxanone) size 0 and conventional sutures according to thefollowing scheme with the locations randomized:

TABLE 2 Barbed Suture Tissue Level Method Conventional Suture MethodDermis Alpha, Simple interrupted loop stitches Zigzag [2-0 nylon, 2-0silk] Subcuticular Corkscrew Simple continuous loop stitches [3-0 PDS]Subcutaneous Corkscrew Simple continuous loop stitches [3-0 PDS]Muscular Corkscrew Simple continuous loop stitches [3-0 PDS]

More than one alpha-shaped stitch was used for longer incisions.

The dogs were housed for two weeks. Daily clinical and necropsyobservations were performed on all surgical sites. With the exceptionthat three of six sites closed by nylon sutures had some sutures chewedout by the dog, all incisions healed normally and no dehiscenceoccurred. The other three sites closed with nylon sutures had a“railroad-tile” appearance, one site in particular being verypronounced. None of the topical skin sites closed with barbed sutureshad such an appearance. This example shows the efficacy of barbedsutures in an in vivo model.

The methods of the present invention have a number of advantages,including improving the biomechanical performance of barbed sutures. Thecurvilinear placement paths of the suture, as contrasted with linearinsertion, provide substantially increased strength for holding theedges of a wound together. Moreover, the insertion of a single suturewith curvilinear techniques replaces the insertion of a plurality ofsutures. The new methods provide an efficient means for a surgeon toclose a wound, reducing the time necessary to place the suture and thetrauma to the patient. Surgeons can quickly and easily utilize thesuturing methods during any type of surgery to quickly join the edges ofa wound in tissue without threading and tying numerous individualstitches. The new suture methods are performed in a manner similar toconventional suturing thus realizing the advantages thereof. The methodsminimize damage to tissue when inserted and minimize scarring or tissuenecrosis across the wound. The sutures can be placed in the tissue in amanner to control and adjust the tension on the suture or thecompression of the tissue.

Although the present invention has been shown and described inconsiderable detail with respect to only a few exemplary embodimentsthereof, it should be understood by those skilled in the art that we donot intend to limit the invention to the embodiments since variousmodifications, omissions and additions may be made to the disclosedembodiments without materially departing from the novel teachings andadvantages of the invention, particularly in light of the foregoingteachings. For example, the methods of the present invention can be usedalone or with other closure methods, such as topical skin adhesives toaid in holding the position of the tissue. Accordingly, we intend tocover all such modifications, omission, additions and equivalents as maybe included within the spirit and scope of the invention as defined bythe following claims.

What is claimed is:
 1. A method of mounting a device to an internalorgan of a subject, the device including at least one eyelet forsecuring the device and through which a suture may pass, using a barbedsuture including an elongated body, first and second sharp pointeddistal ends for penetrating tissue, and a plurality of barbs extendingfrom the periphery of the body, the barbs on a first portion of the bodybetween the first end of the suture and a first axial location on thebody for permitting movement of the suture through the tissue in adirection of movement of the first end and preventing movement of thesuture relative to the tissue in a direction opposite the direction ofmovement of the first end, and the barbs on a second portion of the bodybetween the second end of the suture and a second axial location on thebody which is less than the distance from the second end to the firstaxial location permitting movement of the suture through the tissue in adirection of movement of the second end and preventing movement of thesuture relative to the tissue in a direction opposite the direction ofmovement of the second end, the method comprising the steps of: (a)placing the device in a desired position on an internal organ of thesubject's body, where the internal organ is selected from liver, gallbladder, bowel and stomach; (b) threading-the first pointed end of thesuture through one eyelet; (c) inserting the first pointed end of thesuture into tissue of the internal organ; (d) pushing the first end ofthe suture through the tissue until the first end of the suture extendsout of the tissue at an exit point; (e) gripping the first end of thesuture and pulling the first end out of the tissue while drawing thefirst portion of the suture through the tissue, leaving a portion of thesuture between the first and second axial locations out of the tissueand leaving a length of the first portion of the suture in the tissuebetween the point of insertion and exit point of the first end; (f)after steps (a)-(e), inserting the second pointed end of the suture intotissue of the internal organ; (g) pushing the second end of the suturethrough the tissue until the second end of the suture extends out of thetissue at an exit point, leaving a portion of the suture between thefirst and second axial locations out of the tissue; and (h) gripping thesecond end of the suture and pulling the second end out of the tissuewhile drawing the second portion of the suture through the tissue untilthe device is mounted on the internal organ of the subject's body, andleaving a length of the second portion of the suture in the tissue ofthe internal organ between the point of insertion and exit point of thesecond end; wherein the first and second portions of the suture extendin the tissue in generally opposing directions and cause the suture toresist displacement of the device away from the internal organ.
 2. Themethod of claim 1 wherein at least one of the first and second suturesis inserted in a curvilinear path.